Cleared Traditional

K965182 - RFG-3CF

K965182 is an FDA 510(k) clearance for RFG-3CF, manufactured by Radionics, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K965182 · Radionics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
78d
Days
Class 2
Risk

K965182 is an FDA 510(k) clearance for the RFG-3CF. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on March 12, 1997 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Radionics, Inc. devices

FDA 510(k) Submission Details - K965182

510(k) Number K965182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date March 12, 1997
Days to Decision 78 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 148d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXD Device Classification - Class 2, Special Controls

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXD Generator, Lesion, Radiofrequency

All 30
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K965182.
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RFG-3C PLUS
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LEKSELL NEURO GENERATOR AND ACCESSORIES
K941823 · Elekta Instruments, Inc. · Mar 1996
MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE
K922064 · Cardiotronics, Inc. · Dec 1992